AccessGUDID - DEVICE: Myocene (05430004268000)

GUDID

Device Identifier (DI) Information

Brand Name: Myocene
Version or Model: 1-U
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Myocene

Primary DI Number: 05430004268000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 372401437 *Terms of Use

Device Description: The Myocene device is intended to provide objective measures of muscle fatigue to inform athletic training decisions by coaches and athletes. It is for applications in sport practice, to be used on healthy individuals (athletes), 15 years of age or older, to carry out tests of the extensor muscles of the knee by quantitatively measuring the force of contraction of the healthy quadriceps muscles generated by voluntary contractions and induced by a specific associated powered muscle stimulator, and by using these forces to compute objective measures of quadriceps muscle fatigue

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
67508	Quadriceps fatigue electrostimulation analyser	An electrically-powered device intended to measure muscle fatigue of the quadriceps based on the force of muscle contraction under: 1) noninvasive electrical stimulation at different electrical impluse frequencies (long-term peripheral muscle fatigue); and 2) voluntary exertion before and after exercise (global muscle fatigue). It is in the form of a seat unit with an integrated electrical stimulator, a shin rest with an integrated dynamometer (force sensor), and electrode leads/cables connection points. Muscle fatigue data is typically based on the ratio of force output under different conditions and is analysed and viewed on a connected off-the-shelf computer (not included).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
SDX	Neuromuscular Stimulator And Exercise Evaluation System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 50 and 95 Degrees Fahrenheit
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 30 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 23 and 95 Degrees Fahrenheit
Storage Environment Humidity: between 45 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aafa7bd6-830a-4cae-a934-4e8678894c26
Public Version Date: April 25, 2025
Public Version Number: 1
DI Record Publish Date: April 17, 2025